Duns Number:049735438
Device Description: Reinforced Calcium Alginate Dressing; Reinforced Pad; 4 in. x 4.75 in
Catalog Number
ZCA4475RF
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZCA4475RF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
5c007366-273c-4bd5-8b47-1bf49cd450af
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
April 11, 2019
Package DI Number
20885380108362
Quantity per Package
10
Contains DI Package
00885380108368
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |